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Swine Flu Vaccine May Be Months Away, Experts Say

Federal officials said it would take until January, or late November at the earliest, to make enough vaccine to protect all Americans from a possible epidemic of swine flu.

And beyond the United States and a few other countries that also make vaccines, some experts said it could take years to produce enough swine flu vaccine to satisfy global demand.

Although production is much faster than would have been possible even a few years ago, it still may not be in time to avert death and illness if the virus starts spreading widely and becomes more virulent, some experts said.

In this country, the biggest problem is that despite years of effort, the country is still relying on half-century-old technology to make the flu vaccines.

Federal authorities have spent years and more than a billion dollars trying to shift vaccine production to a faster, more reliable method — one that involves growing the vaccine viruses in vats of cells rather than in hen’s eggs, the old technology. And there are numerous small companies developing totally new approaches that might allow for the production of huge volumes of vaccines in a matter of weeks.

But the cell-based production is not quite ready, and some of the newer techniques are not proven enough to satisfy many experts.

“Those are all great technologies, but it isn’t going to happen in time,” said Dr. Greg Poland, head of the vaccine research program at the Mayo Clinic.

Federal officials have not yet made a decision on whether the swine flu is enough of a threat to warrant vaccine production. But they are taking the initial steps.

A potential problem is that producing swine flu vaccine might interfere with production of the seasonal flu vaccine for next winter.

“We would have to most likely make a compromise,” Andrin Oswald, chief executive of the vaccine division at the drug maker Novartis, said in an interview.

Photo

Some companies like VaxInnate are trying to make flu vaccines from viral genes or proteins, without having to grow the viruses.Credit
Katie Orlinsky for The New York Times

But Robin Robinson, who runs the emergency preparation research program for the federal Department of Health and Human Services, said most manufacturers would have finished producing the bulk of seasonal vaccine by June.

If production of the swine flu vaccine were to start right after that, the first 50 million to 80 million doses would be available by September, Dr. Robinson said.

A full 600 million doses, enough to provide the required two shots for each American, could be finished by January. If immune stimulants called adjuvants were added to the vaccine, that could reduce the dosage needed by each person, allowing enough doses to be ready by late November, he said.

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The vaccine industry is in a much stronger position to respond now than it was five years ago, when the United States had only two flu vaccine suppliers and was hit by a severe shortage.

Now there are five suppliers to the domestic market. And the vaccine industry, once a backwater of the pharmaceutical industry, is attracting new investments, lured by government subsidies and higher prices for vaccines.

Still, a study done with the World Health Organization and the International Federation of Pharmaceutical Manufacturers and Associations estimated that it would probably take four years of production to satisfy fully global demand for a vaccine to protect against the bird flu strain that has concerned health authorities for the last few years.

Similar projections might apply to the swine flu vaccine, some experts say.

“The bottom line is there won’t be enough vaccine quickly enough and the vaccine will largely go to the countries that already produce the vaccine,” because countries will restrict exports in a pandemic, said Dr. David Fedson, an independent expert on pandemic preparedness.

The federal government is encouraging manufacturers to set up production in the United States, since all companies but one, Sanofi-Aventis, now import their flu vaccines.

The government also gave $1.3 billion, spread among several manufacturers, to develop ways of producing the vaccine in vats of animal cells rather than in eggs. Cell culture is less vulnerable to contamination and the process could save at least a few weeks.

The results so far have been mixed. Solvay, which was awarded the biggest federal grant, nearly $300 million, decided it was economically too risky to build a flu vaccine plant in the United States. (Most of the grant money had not yet left federal coffers and will not be lost, Dr. Robinson said.) Sanofi-Aventis has also put cell culture production on the back burner, Dr. Robinson said.

But Novartis is building a cell culture flu vaccine factory in Holly Springs, N.C., which might be ready for use in 2010 or 2011. The federal government is providing nearly $500 million in construction costs and guaranteed vaccine purchases.

A version of this article appears in print on , on Page A10 of the New York edition with the headline: Swine Flu Vaccine May Be Months Away, Experts Say. Order Reprints|Today's Paper|Subscribe